It was reported that during a lead revision procedure on (b)(6) 2023, (manufacturer report number: 1627487-2023-04178), the patient's left s1 lead had fractured during an attempt to explant it and four contacts were abandoned in the sacral epidural space.No further intervention is planned.
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: octrode lead, model: mn10450-50a, batch: ab2367.
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